Heart FailureCardioInsight2NCT05555992
CardioInsight 2 - Non-responder
A study testing Electrical Activation Mapping Guided Cardiac resynchronization therapy in people with Heart Failure, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Electrical Activation Mapping Guided Cardiac resynchronization therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (aged 18 or above) of both sexes
- Ischemic or non-ischemic cause of heart failure
- QRS duration > 120 ms, non -LBBB type of conduction disturbance
- NYHA class III or above
- Informed consent by the patient
- Already received stable dose of guideline directed medical therapy for at least 3 months
Who cannot join
- LBBB patients
- Pregnant women
- Participation in another study
- Patient with contraindication to left ventricle catheterization by a retrograde aortic approach
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Shatin, 999077
Daniel Xu, 35051518 ext. 1518, danielxu@cuhk.edu.hk
About this study
Official title: Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy for Non-responder
Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Conventionally the surgical approach of CRT is to implant one pacing lead in the right heart and one in the left heart to resynchronize the contraction and the pacing lead in the left heart is usually placed in the posterior or lateral portion of the left heart. However, this single approach may not be optimal, especially for those patients with conduction abnormality known to have no response to CRT. Purpose of the clinical investigation. The purpose of the Electrical Activation Guided CRT for Nonresponders Study is to study the effectiveness of an addition of Hisbundle pacing approach to CRT nonresponder by direct His-bundle pacing to improve the responder rate of nonresponder of conventional CRT and a tailored made approach to CRT procedure by using a noninvasive globally mapping system studying the electrical conduction under different approaches to delivery CRT. The pacing approach that optimally corrects conduction abnormality will be determined before the actual addition of new lead procedure.
Conduct of the Investigation This study will include 18 patients already implanted with device delivering conventional CRT that known to have no response to the conventional CRT after 6 months of the CRT therapy from Prince of Wales Hospital, Hong Kong. You will be followed in the device clinic as per usual care after your participation in the study is completed.
- Conditions
- Heart Failure
- Being tested
- Electrical Activation Mapping Guided Cardiac resynchronization therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Activation Mapping Guided Cardiac resynchronization therapyDevice
To study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Electrical Activation Mapping Guided Cardiac resynchronization therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricle end systolic volume reduction
The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram.
Measured: 6 months
Secondary outcomes (17)
Electrical desynchrony index
The acute electrical desynchrony indices (the standard deviation of activation times throughout the epicardium) of different methods of CRT delivery. Lower indicate larger improvement.
Measured: During procedure
Hemodynamic response monitoring
Monitor the difference in hemodynamic responses of different methods of CRT delivery. The hemodynamic response will be maximal dp/dt as measured by pressure wire introduced into the left ventricle during the procedure.
Measured: During procedure
Procedure duration of different methods of CRT delivery
Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.
Measured: During procedure
Implantation success rate of different methods of CRT delivery
Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.
Measured: During procedure
Cine images and chest X ray
Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) of patients will be obtained for evaluation of changes in disease
Measured: 6 months
Echocardiogram parameters: left ventricular systolic and diastolic volume
Echocardiogram parameters: left ventricular systolic and diastolic volume at baseline, 3 months and 6 months.
Measured: 6 months
Echocardiogram parameters: left ventricular ejection fraction
Echocardiogram parameters: left ventricular ejection fraction at baseline, 3 months and 6 months
Measured: 6 months
Echocardiogram parameters: degree of mitral regurgitation
Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months.
Measured: 6 months
Echocardiogram parameters: strain imaging
Echocardiogram parameters: strain imaging at baseline, 3 months and 6 months
Measured: 6 months
Change in New York Heart Association (NYHA) class
Overall changes in QoL measured by change in NYHA class at baseline, 3 months and 6 months.
Measured: 6 months
Device set-up parameter: defibrillation threshold
Device parameters including defibrillation threshold at implant and 6 months follow-up.
Measured: 6 months
Post-operation Complication rate
Peri-operative and 6 months follow-up complications rate:
- Thromboembolic event
- Dislodgement and migration of pacing leads
- Phrenic nerve stimulation
- Others
Measured: 6 months
Change in 6 minute hall walk test
Compare result of 6 minute hall walk test at baseline, 3 months and 6 months.
Measured: 6 months
Change in HF Patient Global Assessment Questionnaire
Compare result of HF Patient Global Assessment Questionnaire at baseline, 3 months and 6 months.
Measured: 6 months
Change in quality of life
Change in quality of life assessed by Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.
Measured: 6 months
Device set-up parameter: defibrillation sensitivity
Device parameters including defibrillation sensitivity at implant and 6 months follow-up.
Measured: 6 months
Device set-up parameter: lead impedance
Device parameters including lead impedance of pacing leads at implant and 6 months follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start2 Jan 2020
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Bryan Ping Yen YAN, Chinese University of Hong Kong
- Investigators
- Byran Yan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555992
- Sponsor's protocol ID
- 2018.215
- Acronym
- CardioInsight2
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy for Non-responder
- ClinicalTrials.gov ID
- NCT05555992
- Acronym / sponsor ID
- CardioInsight2 / 2018.215
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Conventionally the surgical approach of CRT is to implant one pacing lead in the right heart and one in the left heart to resynchronize the contraction and the pacing lead in the left heart is usually placed in the posterior or lateral portion of the left heart. However, this single approach may not be optimal, especially for those patients with conduction abnormality known to have no response to CRT. Purpose of the clinical investigation. The purpose of the Electrical Activation Guided CRT for Nonresponders Study is to study the effectiveness of an addition of Hisbundle pacing approach to CRT nonresponder by direct His-bundle pacing to improve the responder rate of nonresponder of conventional CRT and a tailored made approach to CRT procedure by using a noninvasive globally mapping system studying the electrical conduction under different approaches to delivery CRT. The pacing approach that optimally corrects conduction abnormality will be determined before the actual addition of new lead procedure.
Conduct of the Investigation This study will include 18 patients already implanted with device delivering conventional CRT that known to have no response to the conventional CRT after 6 months of the CRT therapy from Prince of Wales Hospital, Hong Kong. You will be followed in the device clinic as per usual care after your participation in the study is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Electrical Activation Mapping Guided Cardiac resynchronization therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (aged 18 or above) of both sexes
- Ischemic or non-ischemic cause of heart failure
- QRS duration > 120 ms, non -LBBB type of conduction disturbance
- NYHA class III or above
- Informed consent by the patient
Key exclusion criteria (4 listed)
- LBBB patients
- Pregnant women
- Participation in another study
- Patient with contraindication to left ventricle catheterization by a retrograde aortic approach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Activation Mapping Guided Cardiac resynchronization therapyTo study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation | Device | Treatment |
Primary outcome
Left Ventricle end systolic volume reduction
Time frame: 6 months
The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram.
17 secondary outcomes
Electrical desynchrony index
Time frame: During procedure
Hemodynamic response monitoring
Time frame: During procedure
Procedure duration of different methods of CRT delivery
Time frame: During procedure
Implantation success rate of different methods of CRT delivery
Time frame: During procedure
Cine images and chest X ray
Time frame: 6 months
Echocardiogram parameters: left ventricular systolic and diastolic volume
Time frame: 6 months
Echocardiogram parameters: left ventricular ejection fraction
Time frame: 6 months
Echocardiogram parameters: degree of mitral regurgitation
Time frame: 6 months
Echocardiogram parameters: strain imaging
Time frame: 6 months
Change in New York Heart Association (NYHA) class
Time frame: 6 months
Device set-up parameter: defibrillation threshold
Time frame: 6 months
Post-operation Complication rate
Time frame: 6 months
Change in 6 minute hall walk test
Time frame: 6 months
Change in HF Patient Global Assessment Questionnaire
Time frame: 6 months
Change in quality of life
Time frame: 6 months
Device set-up parameter: defibrillation sensitivity
Time frame: 6 months
Device set-up parameter: lead impedance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byran Yan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Activation Mapping Guided Cardiac resynchronization therapy in people with Heart Failure, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Xu (35051518 ext. 1518, danielxu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricle end systolic volume reduction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.